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New Ischemic Cerebral Lesions After Endarterectomy vs. Stenting for the Treatment of Symptomatic Carotid Stenosis (CARECarotid)

Primary Purpose

Carotid Artery Stenosis, Carotid Atherosclerosis, Stroke, Ischemic

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Carotid Artery Stenting
Endarterectomy carotid artery
Sponsored by
Jagiellonian University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carotid Artery Stenosis focused on measuring carotid angioplaty, MRI DWI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria comprised:

  • patient's age ≥ 18 years;
  • 60-99% stenosis of the internal carotid artery (degree of stenosis assessed by means of Doppler sonography, CT angiography or catheter angiography);
  • diameter of the target internal carotid artery not more than 7 mm;
  • symptomatic lesion (a history of ipsilateral stroke, transient ischaemic attack or reversible ischaemic neurological deficit);
  • localisation and morphology of the lesion making possible surgical eversion endarterectomy or endovascular angioplasty with stent implantation;
  • written informed consent.

Exclusion criteria comprised:

  • target lesion that has been previously stented;
  • highly calcified lesions;
  • very tortuous common and internal carotid arteries;
  • occlusion of the contralateral carotid artery without adequate collateral circulation through the circle of Willis (revealed by means of transcranial Doppler sonography);
  • anatomical contraindications for eversion endarterectomy;
  • acute ipsilateral stroke;
  • disabling stroke at any side;
  • other severe pathologies of the brain resulting is significant loss of cerebral tissue and/or significant neurological deficits, such as extensive previous stroke or multiple lacunar infarcts;
  • history of haemorrhagic transformation of ischaemic stroke;
  • severe comorbidities (such as cancer or decompensated heart failure);
  • allergy to aspirin, clopidogrel or ticlopidine;
  • allergy to iodinated contrast media;
  • pregnant women;
  • women of reproductive age who do not use effective contraception;
  • metallic implants (such as peacemakers and orthopaedic endoprostheses) or other known contraindications for magnetic resonance imaging;

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Carotid Artery Stenting

    Endarterectomy carotid artery

    Arm Description

    Subjects will undergo carotid artery angioplasty and stenting with any CE-certificated carotid stent with a proximal protection system Mo.Ma

    Subjects will undergo carotid endarterectomy

    Outcomes

    Primary Outcome Measures

    The purpose of this study is to compare the rate of new ischemic brain injury detectable on MRI after carotid artery stenting and endarterectomy.
    Number of patients with treatment related new ipsilateral cerebral embolic lesions in brain diffusion-weighted magnetic resonance imaging within 2-4 days post carotid artery stenting and endarterectomy. Number, size and location new cerebral lesions per patients in both groups.

    Secondary Outcome Measures

    Any Stroke, TIA, MI or death
    Number of patients with occurrence of any stroke, transient ischemic attack (TIA), myocardial infarction, or death within 6 months after carotid artery stenting and endarterectomy.

    Full Information

    First Posted
    November 29, 2018
    Last Updated
    December 3, 2018
    Sponsor
    Jagiellonian University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03764306
    Brief Title
    New Ischemic Cerebral Lesions After Endarterectomy vs. Stenting for the Treatment of Symptomatic Carotid Stenosis
    Acronym
    CARECarotid
    Official Title
    New Ischemic Cerebral Lesions Revealed by the Imaging Magnetic Resonance Imaging After Endarterectomy vs. Stenting Under Proximal Protection for the Treatment of Symptomatic Carotid Stenosis: Results of a Randomised Prospective Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Terminated
    Why Stopped
    Problem with recruitment of patients meeting the inclusion criteria.
    Study Start Date
    May 1, 2015 (Actual)
    Primary Completion Date
    May 1, 2015 (Actual)
    Study Completion Date
    October 30, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Jagiellonian University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Background and purpose. Even if periprocedural cerebral microembolism associated with carotid endarterectomy or stenting usually does not manifest as clinically overt stroke, neuropsychological disturbances resulting from these events represent an important clinical and socioeconomic problem. Still, it remains unclear whether the use proximal protection can lower the incidence of cerebral embolism associated with the treatment of carotid stenosis. Materials and methods. This was a prospective randomised single-centre study, which was aimed at comparison of surgical eversion endarterectomy with stenting under proximal protection in symptomatic patients. The investigators evaluated the incidence of new ischaemic lesions revealed by the diffusion-weighted magnetic resonance imaging 2-4 days after the treatment and neurologic events.
    Detailed Description
    The CARECarotid was a prospective randomised single-centre study, which was performed in the University Hospital in Kraków. It was planned to evaluate 50 patients presenting with symptomatic lesions of the internal carotid artery. Patients were randomly assigned to one of the two treatment arms: surgical endarterectomy or carotid angioplasty with stenting under proximal protection. All patients provided their written informed consent to undergo the procedures and to participate in this trial. In all surgical patients carotid endarterectomy will perform using the eversion technique. All surgical endarterectomies will perform under cervical block anaesthesia. Perioperatively patients in the surgical arm received aspirin; other antiplatelet or anticoagulant agents were not administered during 5 days before surgery. All procedures in carotid artery stenting will perform with proximal protection system - the Mo.Ma (Medtronic, Minneapolis, MN, USA) device. The investigators will implante stents that were tailored to the localisation of lesions and morphology of carotid arteries: Carotid Wallstent (Boston Scientific, Natick, MA, USA, and in patients with tortuous arteries Precise Pro RX (Cordis, Fremont, CA, USA) or Roadsaver (Terumo, Tokyo, Japan). Patients in the stent arm will receive clopidogrel 75 mg/day and aspirin 75 mg/day. These drugs were administered during 3 days before planned procedure and then 3-6 months after stent implantation. All patients will have MRI DWI performed before and 2-4 days after procedures in both groups. Within 6 months there will be an evaluation of the incidence of neurological events.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Carotid Artery Stenosis, Carotid Atherosclerosis, Stroke, Ischemic
    Keywords
    carotid angioplaty, MRI DWI

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Patients were randomly assigned to one of the two treatment arms: surgical endarterectomy or carotid angioplasty with stenting under proximal protection
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    31 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Carotid Artery Stenting
    Arm Type
    Active Comparator
    Arm Description
    Subjects will undergo carotid artery angioplasty and stenting with any CE-certificated carotid stent with a proximal protection system Mo.Ma
    Arm Title
    Endarterectomy carotid artery
    Arm Type
    Active Comparator
    Arm Description
    Subjects will undergo carotid endarterectomy
    Intervention Type
    Procedure
    Intervention Name(s)
    Carotid Artery Stenting
    Intervention Description
    Carotid artery stenting was considered successful if there was no residual stenosis greater than 20%, and there was no dissection of target artery following the procedure.
    Intervention Type
    Procedure
    Intervention Name(s)
    Endarterectomy carotid artery
    Intervention Description
    Surgical endarterectomy was considered successful if there was no residual stenosis after procedure, without symptoms.
    Primary Outcome Measure Information:
    Title
    The purpose of this study is to compare the rate of new ischemic brain injury detectable on MRI after carotid artery stenting and endarterectomy.
    Description
    Number of patients with treatment related new ipsilateral cerebral embolic lesions in brain diffusion-weighted magnetic resonance imaging within 2-4 days post carotid artery stenting and endarterectomy. Number, size and location new cerebral lesions per patients in both groups.
    Time Frame
    2-4 days after procedure
    Secondary Outcome Measure Information:
    Title
    Any Stroke, TIA, MI or death
    Description
    Number of patients with occurrence of any stroke, transient ischemic attack (TIA), myocardial infarction, or death within 6 months after carotid artery stenting and endarterectomy.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion criteria comprised: patient's age ≥ 18 years; 60-99% stenosis of the internal carotid artery (degree of stenosis assessed by means of Doppler sonography, CT angiography or catheter angiography); diameter of the target internal carotid artery not more than 7 mm; symptomatic lesion (a history of ipsilateral stroke, transient ischaemic attack or reversible ischaemic neurological deficit); localisation and morphology of the lesion making possible surgical eversion endarterectomy or endovascular angioplasty with stent implantation; written informed consent. Exclusion criteria comprised: target lesion that has been previously stented; highly calcified lesions; very tortuous common and internal carotid arteries; occlusion of the contralateral carotid artery without adequate collateral circulation through the circle of Willis (revealed by means of transcranial Doppler sonography); anatomical contraindications for eversion endarterectomy; acute ipsilateral stroke; disabling stroke at any side; other severe pathologies of the brain resulting is significant loss of cerebral tissue and/or significant neurological deficits, such as extensive previous stroke or multiple lacunar infarcts; history of haemorrhagic transformation of ischaemic stroke; severe comorbidities (such as cancer or decompensated heart failure); allergy to aspirin, clopidogrel or ticlopidine; allergy to iodinated contrast media; pregnant women; women of reproductive age who do not use effective contraception; metallic implants (such as peacemakers and orthopaedic endoprostheses) or other known contraindications for magnetic resonance imaging;
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pawel Latacz, PhD MD
    Organizational Affiliation
    Jagiellonian University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    20142180
    Citation
    Cremonesi A, Gieowarsingh S, Spagnolo B, Manetti R, Liso A, Furgieri A, Barattoni MC, Ghetti L, Tavazzi L, Castriota F. Safety, efficacy and long-term durability of endovascular therapy for carotid artery disease: the tailored-Carotid Artery Stenting Experience of a single high-volume centre (tailored-CASE Registry). EuroIntervention. 2009 Nov;5(5):589-98. doi: 10.4244/eijv5i5a95.
    Results Reference
    result
    PubMed Identifier
    20222019
    Citation
    Ansel GM, Hopkins LN, Jaff MR, Rubino P, Bacharach JM, Scheinert D, Myla S, Das T, Cremonesi A; Investigators for the ARMOUR Pivotal Trial. Safety and effectiveness of the INVATEC MO.MA proximal cerebral protection device during carotid artery stenting: results from the ARMOUR pivotal trial. Catheter Cardiovasc Interv. 2010 Jul 1;76(1):1-8. doi: 10.1002/ccd.22439.
    Results Reference
    result
    PubMed Identifier
    22454248
    Citation
    Bersin RM, Stabile E, Ansel GM, Clair DG, Cremonesi A, Hopkins LN, Nikas D, Reimers B, Sievert H, Rubino P. A meta-analysis of proximal occlusion device outcomes in carotid artery stenting. Catheter Cardiovasc Interv. 2012 Dec 1;80(7):1072-8. doi: 10.1002/ccd.24433. Epub 2012 Jul 23.
    Results Reference
    result
    PubMed Identifier
    10942686
    Citation
    Gao MY, Sillesen HH, Lorentzen JE, Schroeder TV. Eversion carotid endarterectomy generates fewer microemboli than standard carotid endarterectomy. Eur J Vasc Endovasc Surg. 2000 Aug;20(2):153-7. doi: 10.1053/ejvs.1999.1072.
    Results Reference
    result
    PubMed Identifier
    21307169
    Citation
    Silver FL, Mackey A, Clark WM, Brooks W, Timaran CH, Chiu D, Goldstein LB, Meschia JF, Ferguson RD, Moore WS, Howard G, Brott TG; CREST Investigators. Safety of stenting and endarterectomy by symptomatic status in the Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST). Stroke. 2011 Mar;42(3):675-80. doi: 10.1161/STROKEAHA.110.610212. Epub 2011 Feb 9.
    Results Reference
    result

    Learn more about this trial

    New Ischemic Cerebral Lesions After Endarterectomy vs. Stenting for the Treatment of Symptomatic Carotid Stenosis

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